NCT00839085

Brief Summary

Study aimed to compare the effect of grape seed extract and ascorbic acid in oxidative stress induced by on pump coronary artery by pass grafting surgery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 6, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 9, 2009

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

February 10, 2009

Status Verified

February 1, 2009

Enrollment Period

2 months

First QC Date

February 6, 2009

Last Update Submit

February 9, 2009

Conditions

CABG-Induced Oxidative Stress

Keywords

CABGon pumpGrape seed extractVit COxidative stress

Outcome Measures

Primary Outcomes (1)

  • LVEF

    Before and after CABG

Secondary Outcomes (4)

  • Total Antioxidant Capacity (TAC)

    Before ischemia, after ischemia, after reperfusion

  • MDA

    Before, middle and after CABG

  • GTX

    Before ischemia, after ischemia, after reperfusion

  • SOD

    Before ischemia, after ischemia, after reperfusion

Study Arms (3)

1

NO INTERVENTION

normal procedure of CABG

2: GSE

ACTIVE COMPARATOR

100 mg GSE every 6h /Po, starting one day before surgery (4 doses in 24h)

Drug: GSE

3: Vit C

ACTIVE COMPARATOR

25 mg/kg through pump

Drug: Vit C (Ascorbic Acid)

Interventions

GSEDRUG

grape seed extract (100 mg/6h), PO

Also known as: Grape Seed Extract
2: GSE
Vit C (Ascorbic Acid)DRUG

Vit C 25 mg/ kg

Also known as: Ascorbic Acid
3: Vit C

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Candidates for elective CABG surgery with pump for first time

You may not qualify if:

  • High risk patients
  • Those who need another heart surgery beside CABG
  • Urgent patients
  • Diabetics
  • Ischemic time more than 120 min

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Research Center

Tabriz, East Azerbaijan Province, 51656-65811, Iran

Location

MeSH Terms

Interventions

Grape Seed ExtractAscorbic Acid

Intervention Hierarchy (Ancestors)

Plant ExtractsPlant PreparationsBiological ProductsComplex MixturesPharmaceutical PreparationsSugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Officials

  • Hossein Babaei, Pharm D, PhD

    Drug Applied Research Center, Tabriz Univ Med Sci

    PRINCIPAL INVESTIGATOR

  • Naser Safaei, MD, Surgeon

    Tabriz Univ Med Sci

    STUDY CHAIR

  • Masood Pezaeshkian, MD

    Tabriz Univ Med Sci

    PRINCIPAL INVESTIGATOR

  • Alireza Yaghobi, MD

    Tabriz Univ Med Sci

    PRINCIPAL INVESTIGATOR

  • Ahmad Reza Jodati, MD

    Tabriz Univ Med Sci

    PRINCIPAL INVESTIGATOR

  • Hossein Babaei, Pharm D, PhD

    Tabriz Univ Med Sci

    STUDY DIRECTOR

  • Rasoul Azarfarin, MD

    Tabriz Univ Med Sci

    PRINCIPAL INVESTIGATOR

  • Mohammad Ali Sheikhalizadeh, CCP

    Tabriz Univ Med Sci

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 6, 2009

First Posted

February 9, 2009

Study Start

November 1, 2008

Primary Completion

January 1, 2009

Study Completion

March 1, 2009

Last Updated

February 10, 2009

Record last verified: 2009-02

Locations

IR(1)